The present invention relates to a food-based delivery system for providing (a) the required nutritional supplements for stimulating production and release of human growth hormone (HGH) and/or (b) a full range and desired dosages of vitamins and minerals consumed each day by serious takers of such supplements. In more detail, the present invention relates to combinations of amino acids, vitamins, and other nutrients formulated into a convenient and good-tasting food such as a food bar or ready-to-drink beverage that, when ingested orally, stimulates HGH production and/or release for the purpose of producing anti-aging effects. The same food is formulated to provide the full range of the most commonly desired vitamins and minerals consumed by adults who are serious consumers of vitamin and mineral supplements or the vitamins and minerals can be formulated separately for ingestion without the HGH-stimulating amino acids and other nutrients. Either way, the food-based delivery system of the present invention provides a full complement of the vitamins, minerals, and other nutritional supplements in adequate quantity to satisfy most serious consumers of such supplements in a pleasant-tasting form.
With regard to the prior art, it is known to those skilled in the art and to many of the public in general, that HGH levels fall with age starting at about age 35, so that HGH levels are reduced by about two-thirds by the age of 60. It is know that when the HGH levels are restored to more youthful levels, by a schedule of either injections of HGH, or the oral consumption of certain combinations of amino acids, over the ensuing 20 to 180 days, anti-aging effects occur, including: boosting of the immune system, restoration of more youthful vigor and libido, increase of the percentage of lean muscle mass, reduction of the percentage of body fat, increase in the thickness of skin with more youthful texture, increased skin turgor and a decrease of brown xe2x80x9cagingxe2x80x9d spots.
The beneficial anti-aging effects of increased levels of growth hormone in humans are well documented. See, for instance, R. Klatz, et al., Grow Young with HGH, New York, HarperCollins Publishers, 1997; see also D. Rudman, et al., Effects of Human Growth Hormone in Men Over 60 Years Old; New England Journal of Medicine, 1990; vol 323; 1:1. In the book by Klatz there are numerous references to published and unpublished studies showing the efficacy of orally ingested amino acids in elevating HGH levels and HGH has long been given by injection. The disadvantages of these prior art methods, however, are several: HGH injections are painful and inconvenient, and the cost usually exceeds $10,000 per year. There can be side effects if the injected dosage is too high for the individual. Injections require careful monitoring of blood laboratory tests and careful physician follow-up. If the person is to take the available pill form of HGH-stimulating amino acids, he/she must take eight to sixteen different pills from four to five different bottles one to four times a day. Some of the pills are quite large, and if one is to take all four of the recommended amino acids in correct dosage, one would have to take is pills from as many as four different bottles at each dosage time, for a total of about 16 pills per dose. Further inconvenience is caused by the fact that the pills of the different bottles run out at different intervals, requiring numerous trips to health food stores. In many locales, some of the ingredients are not available for sale in any store. Typical schedules require taking the pills 6 out of 7 days, with breaks of 2 to 6 weeks every 3 to 6 months, and missing any of the recommended dosages or pills can lessen the desired effects.
Because of the inconvenience of numerous bottles of pills of amino acids, there has been the commercial development and sales of powders of the required amino acids, to be mixed with water, or juice, or milk or even swallowed dry. This method is also inconvenient, and some of the powders available are quite unpalatable. It is not convenient to have to mix powders with water while away from home. Also, according to the prior art, it is recommended that either the pills or the powders be consumed on an empty stomach, with no eating to occur for the next 45 minutes. The reason for this recommendation is that it is known in the prior art that significant elevation of blood glucose, which in turn raises blood insulin levels, will suppress production and release of HGH, because higher blood insulin levels lead to higher levels of somatostatin. Somatostatin is a natural hormone produced by the hypothalamus that suppresses HGH release.
Known in the prior art is the fact that the best four amino acids to ingest for the stimulation of HGH release are L-ornithine, L-arginine, L-glutamine and glycine. However, L-lysine may be substituted for L-ornithine, and usually has been, because L-ornithine has a very bad taste. It has been found that 1200 to 1500 mg of L-lysine, together with 1200 to 1500 mg of L-arginine, will suppress somatostatin, which is especially important in those over age 60, because somatostatin is increased in the older age group. Suppressing somatostatin allows more release of HGH. L-glutamine, about 3,000 to 4,000 grams, and glycine, about 1,000 to 2,000 mg, are recommended as stimulants of the natural hypothalamic hormone called GHRH (growth hormone releasing hormone) which in turn stimulates increased HGH production and release. It is also known that 5 mg of melatonin taken one hour prior to vigorous exercise can triple the increase in HGH resulting from vigorous exercise alone. D. Meeking, et al., Exercise-induced GH Secretion is Enhanced by the Oral Ingestion of Melatonin in Healthy Adult Male Subjects; European Journal of Endocrinology; 1999; vol. 141:22-26.
The powders that contain the appropriate amino acids are available in cans and jars that come with scoopers for measuring dosages into a glass to which water or other beverage is to be added. The problems with this prior art are: consuming the powder dry is very difficult, and many of the powders taste bad, even if mixed with water; if mixed with juice or milk, the fructose or lactose of the juice/milk raises blood glucose and insulin levels, which is counter-productive for HGH release as described above. The whole process of opening individual packets, obtaining an empty glass or cup, and obtaining water can be difficult if dose-time occurs when one is away from home, and even more-so during out-of-town trips. The recommendation, for the powdered products known as Rejuvamin and Revamax (Biocentrics), for example, is for one to four doses per day, with two or more doses being preferred. At each dose time, one to one and one-half scoops, or one unitized packet, must be mixed with water or consumed dry.
One object of the present invention, then, is to provide a new method of stimulating production of HGH for delaying, retarding, and/or partially reversing the effects of aging, in the form of a tasty, convenient food bar, other edible food or ready-to-drink beverage. To stimulate HGH production in this manner goes against the teaching of the prior art because it was believed not to be possible to combine the necessary amino acids with any food for the reasons stated above. In the present invention, use is made of the fact that high protein, low carbohydrate diets and food bars have become quite acceptable, even replacing a certain amount of candy bar sales wherein the candy contains sugar. It is known that protein food bars, protein foods in general, and beverages such as protein shakes, diet sodas, etc., do not significantly raise blood glucose levels or insulin levels if the carbohydrate level in such foods is below 3 grams per serving. The delivery system of the present invention therefore combines the preferred amino acid dosages with food or ready-to-drink beverages that taste good and are convenient, as opposed to the prior art of powders and numerous pills.
In recent years, an increasing number of individuals have begun taking a wide variety of increasing variety and dosages of vitamins, minerals, and other nutritional supplements. Such individuals ingest not only a multivitamin with minerals, each day, but a whole list of additional nutritional vitamin and mineral supplements. To do so, such individuals have had to open and close between 8 to 15 or more bottles of pills at least once each day in order to ingest the many nutritional supplements considered essential. The reason for this is that no one or two pills can be swallowed that would contain all of the ingredients combined. They would be far too large. In addition to a multivitamin with minerals, many people ingest a list that contains some or all of the following each day: vitamin C 500 mg; vitamin E 400 IU; calcium citrate 400 mg; magnesium oxide 200 mg; co-enzyme Q10 50 mg; chromium piccolinate 200 micrograms; and selenium 200 micrograms. Taking just this list of supplements alone generally requires ingestion of about ten pills. Many people take even higher doses of some of the above, plus many other supplements including hormones, amino acids, and herbal preparations such as ginko biloba, saw palmetto and the like. It is therefore not unusual for serious adult takers of supplements to require from 8 to 15 different bottles of pills. The inconvenience is apparent. Travel out of town is an obvious problem where so many bottles of pills are involved. Also, the pills in the various bottles run out on different days, requiring frequent trips to the stores. One can count out pills for the week into piles, then place each day""s pile of pills into a zip-able plastic bag, but such a process is far from convenient.
So far as is known, pills and/or powders are the only way for such individuals to ingest the vitamins, minerals, and other nutritional supplements in the quantities that is desirable. In the prior art, to combine all these vitamin and mineral supplements in sufficient quantity to make the pills or powders unnecessary in a food or beverage form results in a product that is quite unpalatable.
For all of the above reasons, another of the objects of the present invention is to combine all of the desirable doses of vitamins, minerals, and other nutritional supplements into a convenient, tasty food bar, or any other food or ready-to-drink beverage. The food bar has the advantage also of serving as a tasty snack food, in addition to its other uses. The vitamins and minerals, and other hormonal or herbal supplements, can be combined with the anti-aging ingredients into the same food bar or other food or ready-to-drink beverage portion. The same vitamins, minerals, and nutritional supplements can be added to the food bar or other food or ready-to-drink beverage portion without the anti-aging amino acids and melatonin. Or, the anti-aging ingredients can be combined into the food bar or other food or beverage portion without any vitamins, minerals or other supplements. The reasons for each of these three versions of the present invention will be made clear by the following description of the presently preferred embodiments thereof.
The above described objects are achieved by providing an orally ingestible food or ready-to-drink beverage having a caloric content of less than about 300 calories comprising:
(A) the two amino acids, glycine, 1 to 2 grams, and L-glutamine, 2 to 4 grams, plus about 5 mg of melatonin (range of 5 mg to 6 mg) for the purpose of raising HGH levels in order to obtain anti-aging effects in adults over the age of 35 years but generally less than 60 years of age.
(B) The same as (A) but together with the full daily range and dosages of vitamins, minerals and other supplements typically preferred by those who are serious about their daily oral ingestion of such supplements; this version, (B), of the invention is intended to be taken just once a day, whereas (A) may be taken from one to four times a day; the limitation to once a day for (B) is to avoid excessive dosages of vitamins, minerals and other supplements.
(C) The same vitamins, minerals and other supplements as (B), but without the anti-aging ingredients as in (A), for those people under the age of 35 or for people of all ages who do not wish to ingest nutrients that elevate HGH levels.
(D) The same as (A), but with the addition of two additional amino acids, in approximately equal volumes, L-arginine, 1.2 to 1.5 grams, and L-lysine, 1.2 to 1.5 grams; this version of the invention, (D), is intended for individuals of 60 years of age or older, in order to maximize the effectiveness of increasing HGH levels in the bodies of such older persons.
(E) The same as (D), but also comprising the vitamin, mineral and other supplements as in (B).
The food portion, or ready-to-drink beverage portion, common to (A) through (E), comprises mainly protein foodstuffs, with some fat, preferably 4 to 8 grams, but less than 3 grams of carbohydrate per aliquot, and may include flavorings, water, and/or essentially non-caloric sweeteners as needed for appropriate flavors, all formulated to provide a desired volume and taste.
The objects of the invention are also achieved by providing a method for stimulating production of HGH comprising the steps of orally ingesting a palatable, even tasty, convenient food or ready-to-drink beverage comprising a combination of from two to four amino acids as above, and melatonin, and a method of orally ingesting a palatable, even tasty, convenient food or ready-to-drink beverage comprising the full range and daily dosages of vitamins, minerals and other supplements, with or without the above amino acids and melatonin.
In another aspect, the objects of the present invention are achieved by providing an orally-ingestible food having a caloric content of less than about 600 calories comprising proportions of the amino acids L-glutamine and L-glycine in approximately a 2:1 ratio (by weight), and optionally, melatonin in a proportion of approximately 0.001% to about 200% of the proportion of each amino acid; and a combination of protein, carbohydrate, and fat foodstuffs and flavorings formulated to provide a desired volume and taste.
These objects are also achieved by providing a method for stimulating production of human growth hormone comprising the steps of orally ingesting a food comprising a combination of two or more human growth hormone production-stimulating amino acids and melatonin and a combination of vitamins and minerals providing a full complement of the vitamins and minerals ingested each day and ingesting a food comprising a combination of two or more human growth hormone production-stimulating amino acids and melatonin up to four times each day.